Milestone Scientific‘s (OTC:MLSS) said today that the FDA denied the 510(k) application for its Compu-Flo intra-articular computer controlled injection system due to inadequate documentation showing that the device met required equivalency standards.
The Livingston, N.J.-based company said that after meeting with the FDA’s Office of Device Evaluation, it plans to provide additional data, including a new human factor validation study to support a new 510(k) application for the device.
Milestone Scientific said the HFV study, which aims to demonstrate ease-of-use, will cost approximately $100,000.
“We were surprised by the FDA’s response to our application for the intra-articular instrument; however, based on the feedback, we will make the necessary adjustments and resubmit a new application and we are confident that with the results of the incremental HFV Study and other data, 510(k) equivalency will be demonstrated. This development does not detract from our current commercialization initiatives, substantially all of which have focused on our CompuFlo epidural instrument including our recent staffing enhancements, strategic partnerships and key opinion leader relationships. The epidural instrument remains our primary focus among our medical instruments for near term commercialization and revenue,” CEO Leonard Osser said in a press release.
The company said it believes a new 510(k) application supported by the new study will demonstrate appropriate substantial equivalency, but reinforced that there “can be no assurance that the FDA will clear the 510(k) application.”
In June, the company said it completed the pivotal study of its CompuFlo, investigating the safety and efficacy of the epidural space verification of the system.
The 400-patient, multicenter pivotal Compass study looked to compare treatment with the CompuFlo device against the current standard of care for patients undergoing pain management and those undergoing child labor or delivery.
The Compass trial was designed to asses the safety and effectiveness of the epidural space verification of CompuFlow, which identifies and confirms epidural space locations, Milestone Scientific said.